An ear for the chronic

In its January draft guidance on developing drugs to treat acute bacterial otitis media, FDA gave companies two difficult options: either persuade patients with painful infections to enroll in placebo-controlled trials, or run large superiority studies against active comparators.

OctoPlus N.V. is taking a different tack by targeting second- or third-line treatment of chronic otitis media, which it thinks will have a lower bar to approval than the acute indication. The company recently stopped a Phase II trial of OP-145 after an interim analysis of data from 30 adults showed the peptide met the primary endpoint of improvement in eardrum mucosa as assessed by otoscopic scores...